Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

107 results found

Title
Status

 

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

Closed

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

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DiagnosisSolid Tumor, Relapsed Solid Neoplasm, CNS TumorStudy StatusClosed
PhaseI/II
Age2 Years to 17 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: avapritinib (Route: Oral) Other Name: BLU-285
Last Posted Update2024-09-18
ClinicalTrials.gov #NCT04773782
International Sponsor
Blueprint Medicines Corporation
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a phase 1/2 study that studies the drug avapritinib in patients 2-17 years old with solid tumors that have come back (relapsed) or have not responded to previous treatment (refractory). The tumor must have a certain genetic mutation (in KIT, PDGFRA or H3K27M (glioma only)) to qualify you for the study. The study consists of 2 parts; in part 1, more information will be gathered about the drug's safety and how it moves through the body (pharmacokinetics or PK) and in part 2, the effectiveness, safety and PK will continued to be monitored at the recommended dose. 

Inclusion Criteria
  • Patients must be between 2-17 years old
  • Patients must have a diagnosed solid or central nervous system (CNS) tumor that has progressed despite prior standard therapy or no alternative treatment is available 
  • Patients must be able to be up and about at least half of their waking hours (if applicable)
  • Blood work must come back within acceptable ranges within 14 days of the first study dose
  • Patients must not be pregnant on the trial, participants of child bearing potential must agree to use approved contraception methods
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

SNDX-5613-0700 - AUGMENT-101: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX 5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Closed to enrollment

SNDX-5613-0700 - AUGMENT-101: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX 5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

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DiagnosisAcute Myeloid Leukemia Acute Lymphoblastic Leukemia Mixed Lineage Acute Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia of Ambiguous LineageStudy StatusClosed to enrollment
PhaseI/II
Ageup to 18 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: SNDX-5613 (given orally) Drug: Cobicistat (Patients in Phase 1 Arm C patients will receive 150 mg cobicistat daily)
Last Posted Update2024-09-11
ClinicalTrials.gov #NCT04065399
International Sponsor
Syndax Pharmaceuticals
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Jim Whitlock
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a phase I/II study that studies the drug SNDX-5613 in patients with acute leukemia. In phase 1, the dose will be increased to find the maximum tolerated dose of SNDX-5613 and the recommended dose for the next phase will be determined. In phase 2, patients will be given the recommended phase 2 dose determined in phase 1, and the safety and efficacy in patients with various tumour mutation will be studied. 

Inclusion Criteria
  • Patients must have active acute leukemia with certain genetic characteristics
  • Patients must be over 30 days old 
  • Patients must be up and about more than 50% of waking hours (if applicable)
  • Adequate time must have passed from all previous treatments (i.e at least 60 days must have passed from last radiation treatment/stem cell infusion (if applicable))
  • Adeqaute organ function
  • Blood work must come back within acceptable ranges
  • Patients of child bearing potential must be willing to use a highly effective method of contraception from the time of enrollment to 120 days after the last study drug dose
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

LOXO-RET-18036 (LOXO 292) - A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Closed to enrollment

LOXO-RET-18036 (LOXO 292) - A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

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DiagnosisSolid or brain tumour with a change in the RET geneStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (6 Months to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationSelpercatinib is taken by mouth (capsules or oral suspension) Participants <18 years of age may be offered to try a tablet formulation of selpercatinib.
Last Posted Update2024-09-10
ClinicalTrials.gov #NCT03899792
International Sponsor
Loxo Oncology, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well selpercatinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a change in a gene called RET. 

Selpercatinib may stop the growth of cancer cells with RET gene changes by blocking the RET enzymes needed for cell growth.

Inclusion Criteria
  • Age between 6 months and 21 years
  • Solid tumors and brain tumours with a change in a gene called RET
  • Cancer that has come back (relapse) or is not improving despite treatment (progression)
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

MK-4280-003 - A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

Open

MK-4280-003 - A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

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DiagnosisHodgkin Disease Lymphoma, Non-Hodgkin Lymphoma, B-CellStudy StatusOpen
PhaseI/II
Age18 Years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: Pembrolizumab (KEYTRUDA®) Administered as an IV infusion every 3 weeks (Q3W) Biological: Favezelimab (MK-4280) Administered as an IV infusion Q3W
Last Posted Update2024-08-21
ClinicalTrials.gov #NCT03598608
International Sponsor
Merck Sharp & Dohme LLC
Principal Investigators for Canadian Sites
CancerCare Manitoba - Dr. Leonard Minuk
Centres
Medical contact

Sarcoma - Dr. Sapna Oberoi

soberoi@cancercare.mb.ca

Social worker/patient navigator contact
N/A
Clinical research contact

Rebekah Hiebert

rhiebert5@cancercare.mb.ca

Kathryn Dyck

kdyck5@cancercare.mb.ca

 

 

Study Description

This study will evaluate the combination of two drugs called favezelimab and pembrolizumab to see how effective and safe it is for treating patients with a cancer called lymphoma. There are various different kinds of lymphoma, this study is for patients with classical Hodgkin, indolent non-Hodgkin or diffuse large B-cell lymphoma. 

Inclusion Criteria
  • Participants must be 18 years of age or older 
  • Participants must have a diagnosis of:
    • classical Hodgkin lymphoma (cHL)
    • diffuse large B-cell lymphoma (DLBCL)
    • indolent non-Hodgkin lymphoma (iNHL)
  • Must have a tumour that can be measured on CT or MRI 
  • Participant should be well enough to carry out light daily tasks, e.g., light house work, office work, normal activities

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

DAY101-102 - A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations (FIRELIGHT)

Closed

DAY101-102 - A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations (FIRELIGHT)

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DiagnosisNon-hematological tumours (solid and brain) with relevant biomarkerStudy StatusClosed
PhaseI/II
Age12 Years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: DAY101 (Oral tablet) Drug: Pimasertib Hydrochloride (Oral capsule) - Sub-study B only.
Last Posted Update2024-07-31
ClinicalTrials.gov #NCT04985604
International Sponsor
Day One Biopharmaceuticals, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 

This is a Phase 1b/2 study of the drug DAY101 in patients ≥12 years of age with solid tumours or brain tumours that have come back or progressed. This study includes 2 sub-studies, patients in sub-study A will receive the DAY-101 drug and patients in sub-study B will receive "DAY-101" and another drug called pimasertib in combination.

Inclusion Criteria
  • Participants must be between 12 to 18 years old
  • Participants must have a solid tumour or brain tumour that has come back (relapsed) or progressed 
  • Participants must have a qualifying gene change in the tumour (MAPK pathway)
  • If enrolled on study, patients and their families must agree to the study requirements by signing an informed consent/assent form

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

BP42573 - An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III

Open

BP42573 - An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III

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DiagnosisGlioblastomaStudy StatusOpen
PhaseI
Age18 Years and olderRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: RO7428731, intravenously (IV)
Last Posted Update2024-06-21
ClinicalTrials.gov #NCT05187624
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

Study Description

 

A clinical trial to look at how safe and tolerable the drug RO7428731 is at different doses, how the body processes it, and if there are any early signs of treatment efficacy of RO7428731 in patients with glioblastoma that has the marker EGFRvIII

Via: Clinical Trial – Glioblastoma – Safety, Tolerability, Pharm... (roche.com)

Inclusion Criteria
  • Diagnosis of glioblastoma with a tumour expression called EGFRvIII
  • Must have completed standard of care therapy prior to joining this study
  • Must be up and about at least 70% of their waking hours
  • Adequate organ functions prior to start of study treatment
  • Willingness to abide by contraceptive measures for the duration of the study.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team

NETTER-P - A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

Open

NETTER-P - A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

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DiagnosisGastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, ParagangliomaStudy StatusOpen
PhaseII
Age12 to 17 Years OldRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Lutetium [177Lu] oxodotreotide/dotatate (Other Name: Lutathera) Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Last Posted Update2024-06-21
ClinicalTrials.gov #NCT04711135
International Sponsor
Advanced Accelerator Applications
Principal Investigators for Canadian Sites
CHU de Québec – Université Laval – Dr François-Alexandre Buteau
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

 

This is a phase 2 study designed to evaluate the safety of a drug called Lutathera in patients 12 to <18 years old with GEP-NET and PPGL disease. For patients on the study, this drug will be infused 4 times at 8-week intervals. After the infusions are complete, a follow-up period will take place after the last dose for each patient who received at least one dose of Lutathera.

Inclusion Criteria
  • Patients must have a diagnosis of GEP-NET or PPGL that has gotten worse or can not be operated on
  • Patients must be between 12 to <18 years old at the time of enrollment
  • Patients must be up and about for over half of their waking hours
  • Patients and their families (as applicable) must agree to sign the written informed consent forms outlined by the study team

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

LOGGIC/FIREFLY-2 - LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

Open

LOGGIC/FIREFLY-2 - LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

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DiagnosisLow-grade GliomaStudy StatusOpen
PhaseIII
Ageup to 25 YearsRandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationExperimental: Arm #1 - Tovorafenib (DAY101), oral
Last Posted Update2024-05-31
ClinicalTrials.gov #NCT05566795
International Sponsor
Sponsor:
Day One Biopharmaceuticals, Inc.

Collaborator:
SIOPe Brain Tumor Group LOGGIC Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 

This is a Phase 3 study to evaluate how safe and effective a drug called tovorafenib is when compared to standard of care chemotherapy. This study is for patients with low-grade glioma (LGG) who have a genetic mutation called a RAF alteration. 

Inclusion Criteria
  • Patients must be under 25 years of age to participate
  • Must have a diagnosis of a low grade glioma that has RAF alteration 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.